Prescribing Information

For Patients

Dilantin Kapseals (extended phenytoin sodium) is an antiepileptic drug used to control generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and to prevent and treat seizures occurring during or following neurosurgery. This medication is available in generic form. Common side effects include headache, nausea, vomiting, constipation, dizziness, drowsiness, trouble sleeping, or nervousness.

Patients who have received no previous treatment may be started on a dose of one 100-mg Dilantin three times daily and the dosage then adjusted to suit individual requirements. For most adults, the maintenance dosage will be one capsule three to four times a day. Dilantin Kapseals may interact with azapropazone, delavirdine, dofetilide, etravirine, nisoldipine, rilpivirine, colesevelam, molindone, pyridoxine (vitamin B6), sucralfate, sulfa drugs, telithromycin, amiodarone, azole antifungals, cimetidine, antibiotics, estrogens, isoniazid, rifamycins, St. John's wort, other anti-seizure medicines, drugs to treat cancer, steroids, cyclosporine, felodipine, quetiapine, quinidine, theophylline, vitamin D, warfarin, phenothiazines, antidepressants, or hormonal birth control such as pills, patch, or ring. Tell your doctor all medications and supplements you use. Dilantin Kapseals are not recommended for use during pregnancy. It may harm a fetus. Breastfeeding is not recommended while taking Dilantin Kapseals because this drug appears to pass in low concentrations into breast milk. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Dilantin Kapseals (extended phenytoin sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

SIDE EFFECTS: Headache, nausea, vomiting, constipation, dizziness, feeling of spinning, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Phenytoin may cause swelling and bleeding of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, high fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Central Nervous System: The most common manifestations encountered with
phenytoin therapy are referable to this system and are usually dose-related.
These include nystagmus, ataxia, slurred speech, decreased coordination, and
mental confusion. Dizziness, insomnia, transient nervousness, motor twitchings,
and headaches have also been observed. There have also been rare reports of
phenytoin induced dyskinesias, including chorea, dystonia, tremor, and asterixis,
similar to those induced by phenothiazine and other neuroleptic drugs.

Integumentary System: Dermatological manifestations sometimes accompanied
by fever have included scarlatiniform or morbilliform rashes. A morbilliform
rash (measles-like) is the most common; other types of dermatitis are seen more
rarely. Other more serious forms which may be fatal have included bullous, exfoliative
or purpuric dermatitis, lupus erythematosus, Stevens-Johnson syndrome, and toxic
epidermal necrolysis (see PRECAUTIONS section).

Hemopoietic System: Hemopoietic complications, some fatal, have occasionally
been reported in association with administration of phenytoin. These have included
thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia
with or without bone marrow suppression. While macrocytosis and megaloblastic
anemia have occurred, these conditions usually respond to folic acid therapy.
Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma,
and Hodgkin's disease have been reported (see WARNINGS
section).